Multicenter Randomized Trial of Everolimus in Pediatric Heart Transplantation
Abstract
TEAMMATE is a multicenter randomized clinical trial of a novel immunosuppressive therapy that is studying children who have undergone recent heart transplantation. The primary goal is to determine whether a new rejection treatment (everolimus and low-dose tacrolimus) can reduce or prevent complications of transplant, including rejection, coronary artery disease, and kidney disease, when compared to usual care (tacrolimus and mycophenolate mofetil). The secondary goal is to acquire FDA approval of the first immunosuppression regimen for, pediatric heart transplantation. The primary trial endpoint is a validated surrogate measure--the major adverse transplant event (MATE) score--which efficiently predicts long-term survival, and that has been accepted by the FDA (IND# 127980). The trial is being conducted at 25 centers, with leadership at Boston Children's Hospital (Data Coordinating Center) and Stanford University (Clinical Coordinating Center). At the time of this annual report, trial execution is complete (211 enrolled and followed for 30 months) and data analysis/results dissemination activities remain. Additional accomplishments in Year 06 include completion of endpoint adjudication and centralized angiography interpretations; completion of biospecimen collection (59 plasma samples); successful execution of a Data and Safety Monitoring Board meeting (Nov 2022); publication of the Trial Design paper and acceptance of a research abstract for the Trial Main Results to the American Heart Association Scientific Sessions Late-Breaking Science platform..
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2023
- Accession Number
- AD1224437
Entities
People
- Lynn A Sleeper